Kornimate/medical-research-clean huggingface dataset:
t1d closed-loop and physical activity

Conditions: Diabetes type1

Summary: "physical activity is recognized as beneficial for patients living with type 1 diabetes (t1dm), with a demonstrated effect not only on hba1c control \[1\] but also on reducing the incidence of diabetes-related complications \[2,3\]. it is recommended that patients living with t1dm perform 150 minutes of accumulated physical activity per week, without exceeding two consecutive days without physical activity \[4\]. indeed, one meta-analysis reported that moderately vigorous activity (≥4.5 mets) was beneficial compared with lower-intensity activity, while three other studies noted that only vigorous physical activity (≥6 mets) predicted lower all-cause mortality rates \[5\]. however, t1dm can represent a major obstacle to physical activity because of the occurrence of fairly frequent hypoglycemia, including after physical effort, the need for early resugaring but also the risk of hyperglycemia (rebound or with certain activities) \[6\]. the advent of automated insulin delivery systems has led to a significant improvement in time on target and a reduction in the frequency of hypoglycemia, including during physical activity in some studies \[7-9\]. the aim of this study is therefore to evaluate, in a cohort of patients with t1dm, whether the implementation of a closed-loop automated insulin delivery system increases physical activity in patients with t1dm. based on the interpretation of the onaps-paq \[10\], the investigator hypothesize that the implementation of the closed-loop system enables an individual to reach the 3000 met/min/week threshold (considered ""active+"" from this threshold onwards).


Eligibility criteria:
inclusion criteria: * type 1 diabetes defined by clinical history and positive measurement of autoantibodies (anti-gad or ia2), evolving for more than 6 months and treated by insulin pump for at least 6 months, for whom an indication for automated insulin delivery is retained, by criteria of glycemic control (hba1c ≥ 8% and/or significant glycemic variability and/or severe hypoglycemia) or poor quality of life, in accordance with reimbursement criteria validated by the cnam for available systems. * for women, existence of effective contraception (hormonal or mechanical) and no plans for pregnancy during the study period. * having a health care insurance."" " exclusion criteria: * patient already involved in another experimental study * patient in a particular situation deemed incompatible with the study by the investigator * patient living in a department other than alpes-maritimes or var * pregnant women * presence of a contraindication to physical activity * patient with linguistic or psychological incapacity to understand written information * patient refusing to give consent * patient deprived of liberty by administrative or judicial decision, under guardianship or trusteeship"" "
silastic stent study

Conditions: Pituitary Tumour

Summary: endoscopic skull base surgery is a relatively new procedure that is now a standard of care for surgeries at the base of the skull; however there are no studies that examine the healing process of the nasal lining with the use of silastic (silicone) stents (or splints) that might be placed at the time of surgery. while there is some evidence to suggest that the use of stents improves wound healing, the decision to use a stent or not is currently up to the preference of the surgeon. to investigate the impact of stents on post-surgical healing, the investigators at vancouver general hospital will compare patients undergoing trans-sphenoidal pituitary surgeries with septal flap reconstruction with the use of silastic stents to line the septal donor site, and compare their recovery to those who did not receive stents. the investigators hypothesize that the use of silastic stents in endonasal surgery increases the rate of mucosal healing, and better quality mucosal regeneration, and with no effect on the patients experience after surgery. in this randomized control trial the investigators aim to recruit 26 (13 in each arm) study participants. the primary outcome is to determine the effect of silastic stunting on healing of the naso-septal flap donor site. this objective will be achieved by assessment of endoscopic photographs of healing tissue and histologic assessment of healing tissues. the secondary outcome involves questionnaires that measure the patient's subjective nasal symptoms prior to and following endoscopic skull based surgery. total time commitment for the study participant is about 4 months across 4 study visits (all of which are part of standard of care): the assessment visit, surgery, 4 weeks post-operative follow up visit and 12 week post-operative follow up visit.


Eligibility criteria:
inclusion criteria: * patients undergoing trans-sphenoidal endoscopic pituitary surgery at their first post-operative appointment exclusion criteria: * patients with inflammatory sinus conditions * patients having undergone extensive skull base reconstructions * patients having received previous radiotherapy

Keywords: silastic stenting trans-nasal endoscopic surgery post-operative intra-nasal re-mucosalization
stage ii/iii colorectal cancer recurrence

Conditions: Colorectal Cancer; Colorectal Adenocarcinoma; Colorectal Cancer Stage II; Colorectal Cancer Stage III; Colorectal Cancer Recurrent

Summary: this study will develop an assay to predict disease recurrence in patients with stage ii/iii crc after receiving adjuvant chemotherapy, using genome-wide dna methylation.

adjuvant chemotherapy (act) is the standard clinical care for patients with stage iii or high-risk stage ii colorectal cancer (crc) after curative-intent resection. nonetheless, more than 30% of patients experience crc recurrence. accurate prediction of recurrence risk in stage ii/iii crc patients who undergo act is crucial for determining the necessity and duration of act, as well as for tailoring novel treatment strategies for these patients. this study will comprise three phases 1. a systematic and comprehensive cpg methylation-based epigenetic biomarker discovery phase to identify the differentially methylated cpg sites associated with recurrence-free survival (rfs) \ 5 years. in this phase, lasso-based machine learning algorithms will be used to optimize the biomarker candidates. 2. a tissue-based clinical assay development phase by quantitative pyrosequencing 3. an independent validation phase. at completion, this study will validate a tissue-based assay to predict the development of recurrence after the completion of chemotherapy in patients with stage iii and ii crc

Eligibility criteria:
inclusion criteria: * stage ii (high-risk) or iii colorectal cancer (tnm classification, 8th edition). * received standard diagnostic, staging, and therapeutic procedures as per local guidelines * received stage-specific curative-intent resection followed by adjuvant chemotherapy. * confirmed cancer-free survivorship confirmed at the time of study inclusion. exclusion criteria: * lack of written informed consent. * development of recurrence in the first 6 months following adjuvant chemotherapy completion. * hereditary colorectal cancer syndromes (identified through genetic testing) * inflammatory bowel diseases

Keywords: recurrence-free survival (rfs) overall survival (os) methylation dna methylation carcinoembryonic antigen (cea)
estimation of vascularization after treatment of deep rectovaginal endometriosis node by rectal shaving

Conditions: Deep Endometriosis; Recto Vaginal Node

Summary: indocyanine green is a dye, using in surgery to bring out the intraoperative evaluation of tissue perfusion. after intravenous injection of indocyanine green, using a near infrared light, the vascularisation becomes fluorescent. in endometriosis disease, the treatment of recto vaginal node can be complicated by rectovaginal fistula. an abnormal vascularisation related to the surgery would be a risk factor of post operative fistulas. the aim of this study is to evaluate the rectal and vaginal vascularisation during the treatment of a recto vaginal endometriosis nodule with rectal shaving, using indocyanine green fluorescence.

investigators are going to inject, at the end of a rectal shaving, a bolus of 0,2mg/kg of indocyanine green after dilution (2,5mg/ml). with de spies system (karl storz gmbh \& co. kg, tuttlingen, germany), the vascularisation would be imediately fluorescent. investigators are going to estimate the vascularization of the rectal serosa and mucosa where the nodule was located. if a vaginal resection has been performed, investigators are going to estimate the vascularization of the vaginal scar. to estimate de vascularization, investigators are going tu use a scale with a score between 0 and 4. after the surgery, the post-operative follow-up with be the same as usual after a rectal shaving.

Eligibility criteria:
inclusion criteria: * patients above the age of 18 year * patients with endometriosis recto vaginal node * patients with operative indications of rectal shaving, with or without vaginal resection * patients who have accepted to participate exclusion criteria: * minors patients * patients under guardianship or wardship * patients who refused the participation * iodine allergy * pregnant woman * patients during lactation

Keywords: indocyanine green fluorescence rectal vascularisation vaginal vascularisation laparoscopic surgery rectal shaving recto vaginal node deep endometriosis
evaluation of the glycaemic control with insulin detemir as an add-on to current oral anti-diabetic drug treatment in subjects with type 2 diabetes in korea

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. this trial aims for evaluating the glycaemic control, measured as glycosylated haemoglobin (hb1ac), of once daily insulin detemir as an add-on to oral antidiabetic drug (oad) in subjects with type 2 diabetes mellitus in korea.


Eligibility criteria:
inclusion criteria: * type 2 diabetes (diagnosed more than 12 months ago) * hba1c greater than 7.0 and less than 12.0% at screening * currently on any oad in more than 3 months ago * bmi (body mass index) less than 35kg/m2 exclusion criteria: * previous treatment with insulin in more than 7 days within the last 3 months * uncontrolled treated/untreated hypertension (systolic blood pressure greater than 180mmhg and/or diastolic blood pressure less than 110mmhg)
effect of aerobic exercise on stress and fatigue of lactating employed women

Conditions: Stress; Fatigue

Summary: the study aims to determine the effect of aerobic exercise on stress and fatigue of employed lactating women.

the study aims to determine the effect of aerobic exercise on stress and fatigue of employed lactating women. this study will be carried out on sixty lactating mothers working in the medical field who have returned to work after maternity leave and suffering from stress and fatigue. the subjects will be divided randomly into two groups equal in number, the aerobic exercise group ( group a) and the control group ( group b). group a will consist of thirty employed lactating women suffering from stress and fatigue. these women will perform aerobic exercise for 30 minutes for each session, 5 times per week, for 6 weeks in the form of treadmill training (60- 70% of hr max) and do some modifications of their routine by following lifestyle modification advice given to them during the 6 weeks of the program period. control group (group b): this group will consist of thirty employed lactating women suffering from stress and fatigue. this group will receive the same lifestyle modification advice that will be given to group (a) during the six weeks of the program period.

Eligibility criteria:
inclusion criteria: * all participants are lactating mothers. * working in the medical field 4 to 6 hours per day, 4 to 5 days per week. * returned to work after 4 months of maternity leave. * suffering stress and fatigue considering the perceived stress questionnaire and the fatigue assessment scale. * their babies' ages will be ranged from 6 to 8 months old. * having at least one year of work experience before giving birth. * their age will be ranged from 25 to 35 years. * they haven't exercised more than twice per week during the previous 3 months. exclusion criteria: * any neurological, cardiovascular disorders, or metabolic disease * physical impairments that prevent following the program. * women who are planning to stop breastfeeding in the next 4 months. * women with regular medications. * mothers of formula feeding babies. * women who are smoking will be excluded from this study.
epo906 plus radiation therapy for the treatment of cancer patients

Conditions: Central Nervous System Neoplasms; Head and Neck Neoplasms

Summary: the purpose of this study is to determine the safety of the drug epo906 that could shrink tumors when used with radiation therapy in cancer patients.

* to determine the maximum tolerated dose (mtd) of epo906 administered in combination with radiation therapy and establish a recommend phase ii dose. * to evaluate the safety and toxicity profile of epo906 when administered concurrently with radiotherapy in three disease cohorts. * to evaluate tumor response.

Eligibility criteria:
inclusion criteria: * requires a minimum of 3 weeks of radiation therapy * solid tumors with advanced or recurrent disease for which there is no standard therapy or tumors have failed standard therapy * world health organization (who) performance status equal to or less than 2 * life expectancy equal to or greater than 3 months exclusion criteria: * any peripheral neuropathy * unresolved diarrhea greater than grade 1 * patients who received any other investigational compound within the past 28 days * severe cardiac insufficiency * patients on coumadin

Keywords: cns and head and neck cancers histologically confirmed cns malignancy head and neck there is on standard therapy or have failed standard therapy
exogenous effects of standard medical care (dopamine) on motor learning of an upper limb task in parkinson disease

Conditions: Parkinson Disease

Summary: the study determines whether standard medical care (dopamine) affects learning and retention of an upper limb feeding task in people with parkinson's disease (pd) and whether training on the feeding task generalises to performance on an untrained upper limb buttoning task. half the participants will train on the feeding task after they have taken their first dose of dopamine for the day (i.e. "on" medication state), while the other half will train on the same feeding task before taking their first daily dose of dopamine (i.e. "off" medication state).

parkinson disease (pd) is an age related neurodegenerative disorder with symptomatic declines in motor function due to a loss of dopaminergic neurons within the basal ganglia. ironically, treatment with exogenous dopamine-replacement medication (e.g. levodopa) may have positive effects on existing motor skills such as handwriting or walking, but may have detrimental effects on the learning of motor skills necessary for effective rehabilitation. although dopamine medications are routinely prescribed to replace lost dopamine in the sensorimotor areas of the striatum, they may actually be "overdosing" the associative striatum, a candidate neuroanatomical correlate for motor learning. to date, however, this 'overdose' hypothesis has not been widely tested, given that few studies of motor learning in pd have reported or controlled for whether individuals were tested "on" or "off" their dopamine replacement medication.

Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease confirmed by neurologist * hoehn and yahr stages 1 to 3 * on a stable dose of antiparkinsonian medication for the past month and will continue on this regime for at least another subsequent month * walks unaided exclusion criteria: * not taking dopamine replacement therapy * with prior surgical management for pd (e.g. deep brain stimulation) * with medication-resistant freezing of gait * significant cognitive impairment (montreal cognitive assessment score \<18) * unstable medical conditions * other neurological conditions * unable to follow instructions or safely complete the training tasks
a phase ii study of zd1839 and tamoxifen in patients with epithelial ovarian carcinoma, cancer of the fallopian tube or the peritoneum refractory to platinum- and taxane-based therapy

Conditions: Ovarian Cancer; Cancer of the Fallopian Tube; Peritoneal Cancer

Summary: although initially responsive to cytoreductive surgery and platinum- and/or taxane-based chemotherapy, a majority of patients with epithelial ovarian cancer, cancer of the fallopian tube or the peritoneum will eventually relapse. recurrence within 6 months after completing platinum-containing chemotherapy indicates a platinum-refractory cancer disease. new therapeutic strategies are required in platinum-refractory disease. inhibition of growth signals induced by the epidermal growth factor receptor pathway, or by the estrogen receptor pathway provides promising targets in epithelial ovarian cancer, cancer of the fallopian tube or the peritoneum. the trial is to evaluate the safety and tolerability of the combination of the epidermal growth facto tyrosine kinase inhibitor zd1839 and the clinically established antiestrogen tamoxifen.


Eligibility criteria:
inclusion criteria: histologically confirmed epithelial ovarian cancer, cancer of the fallopian tube or peritoneum refractory to platinum- and taxane-based chemotherapy measurable or non-measurable disease written informed consent aged 18 years or older karnofsky performance status \> 60% exclusion criteria: complete bowel obstruction symptomatic brain metastases known hypersensitivity to evaluated drugs inadequate kidney function inadequate hepatic function evidence of clinically active interstitial lung disease history of congestive heart failure \> nyha 2

Keywords: cancer cancer alternative therapies ovarian cancer tyrosine kinase inhibitor
general practitioner's place in the treatment of fracture osteoporosis in the elderly

Conditions: Osteoporosis

Summary: osteoporosis is a major public health problem. its screening and its treatment remain largely insufficient while therapies have demonstrated their effectiveness. in the event of a severe fracture, the update of the 2016/2017 recommendations, prepared by the research and information group on osteoporosis and the french rheumatology society, concerning osteoporosis recommends a specific treatment with bisphosphonates as first-line treatment, without bone densitometry, regardless of age. the frequency of prescribing anti-osteoporotic treatment as an outpatient after a fracture of the upper extremity of the femur is very low (2% to 21% according to the studies). the main factors associated with non-prescription found are co-morbidities (charlson score\> 6), dementia, obesity (bmi\> 30), chronic alcoholism, male sex, polypharmacy\> 4, age. conversely, the factors associated with prescribing are recurrent falls (\> 2 / year), a history of osteoporotic fracture, an iso resource group\> 3, female sex, and corticosteroid therapy.

1. / the collection of patients' characteristics upon admission will be based on the computerized patient file and the paper file: socio-demographic data, co-morbidities, functional status, entry / exit treatments, place of residence, source, balance sheet hospital. 2. / determination with the treating doctor or the pharmacist of the prescriptions of the anti-osteoporotic treatments at 6 months of the hospital care. 3. / research factors associated with the prescription (or non-prescription) of anti-osteoporotic treatments.

Eligibility criteria:
inclusion criteria: * subjects aged 75 or over (hospitalization criteria in the pathway), admitted to the ortho-geriatric ward of the saint malo hospital center, treated for a fracture of the upper extremity of the femur. exclusion criteria: * high-energy fracture, pathological fractures (infection, tumor), persons of legal age subject to legal protection (safeguard of justice, guardianship, guardianship), persons deprived of their liberty.
safety study of il-21/anti-pd-1 combination in the treatment of solid tumors

Conditions: Neoplasms by Site

Summary: the purpose of this study is to determine whether the combination of the 2 drugs being investigated (il-21 and anti-pd-1) is safe, and provide preliminary information on the clinical benefits of two different schedules of the combination.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * all subjects will have locally advanced or metastatic solid tumors * for part 2 (cohort expansion): * tumor types will be restricted to clear cell renal cell carcinoma (ccrcc), non-small cell lung cancer (nsclc), and melanoma * at least 1 lesion with measurable disease * only subjects with tumor samples that are pd-l1 positive or negative are eligible exclusion criteria: * uncontrolled central nervous system (cns) or leptomeningeal metastasis * inadequate liver or kidney function * history of autoimmune disease
study of depression-ketamine-brain function

Conditions: Major Depression

Summary: targeting the glutamatergic system to treat depression is a new and promising strategy based on studies at the molecular, synaptic, and neuronal level but also on results of studies conducted in animal models and first clinical studies involving depressed patients.ketamine has been proposed as a novel approach to induce rapid antidepressant response. in this pilot project the investigators aim to introduce this novel and promising approach into clinical practice. besides the assessment of clinical efficacy, the investigators will put a special emphasis on the assessment of ketamine-associated effects on brain function using fmri and cognitive testing.


Eligibility criteria:
inclusion criteria: * men and women aged 18 to 65 years with a diagnosis of major depressive disorder without psychotic features. * drug-resistant depressed patients (defined as non-response to two sufficiently long (at least 6 weeks) drug trials at the maximal authorized or tolerated dose) * score 25 or higher on the montgomery-asberg depression rating scale * stable psychotropic medication (antidepressants, antipsychotics, mood stabilizers) during the last 6 weeks prior to inclusion. * legally competent subjects agreeing to comply with the requirements of the study and authorizing the transmission of relevant information to competent physicians in the case of a clinically relevant previously unknown finding during an mri examination. exclusion criteria: * subjects with co-morbid substance abuse or dependence during the 3 months prior to inclusion, except nicotine consumption. * patients judged to be at serious suicide risk (score ≥ 4 at item 10 of the madrs). * patients with any other dsm-iv axis one diagnosis including bipolar disorder except for anxiety disorder which are not dominating the clinical presentation. * history of antidepressant or substance-induced hypomania or mania. * history of psychotic symptoms. * patients with any contra-indication to the administration of ketamine, especially present diagnosis or antecedents of clinically relevant cardiovascular disorders (clinically significant or not adequately treated hypertension, present or previous diagnosis of cardiovascular disorder such as stroke or heart attack etc). * any mri contraindication, especially metallic implants, pacemaker, etc. * pregnant women, breast-feeding women, women of childbearing age without effective means of contraception. * treatment during the last 2 weeks with thyroid hormones and sympathicomimetic drug. * present or past diagnosis of eclampsia or preeclampsia. * untreated or insufficiently treated hyperthyroidism. * known hypersensitivity to ketamine or to the excipient (benzethonium chloride). * present or past diagnosis of glaucoma, intracranial hypertension.

Keywords: depression, ketamine, fmri